FDA Device Recall Z-1539-2021

INNOVA MEDICAL GROUP, INC. · Pasadena, CA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

COVID-19 Self-Test Kit *** INNOVA *** 3T

Lot / serial / GTIN: Catalog Number: 3T Lot Numbers: U2102003 X2012310

Quantity: 402 boxes (=1,206 tests)

Reason for recall

Due to distributing test kits to customers who were not part of a clinical investigation.

Recall record

Recall number: Z-1539-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.
Recall initiated: 2021-04-09
Classified by FDA Center: 2021-06-10
FDA published: 2021-06-16
Recalling firm: INNOVA MEDICAL GROUP, INC.
Firm location: Pasadena, CA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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